Bosutinib STADA
Bosutinib Stada is a medicine used to treat a type of blood cancer called chronic myeloid leukemia (CML) in adults.
Form
tabletti, kalvopäällysteinen
Strength
100 mg
Active Ingredient
Bosutinib
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
For newly diagnosed CML, the usual dose is 400 mg once daily. For CML that has not responded to other treatments, the usual dose is 500 mg once daily. Your doctor may adjust your dose if you have kidney problems.
Method
Take the tablet(s) once daily with food. Swallow the tablets whole with water.
Important
The maximum recommended daily dose is 500 mg, but your doctor may adjust it based on your condition and response to treatment.
Possible Side Effects
COMMON
- •Low numbers of platelets, red blood cells, or certain white blood cells (neutrophils)
- •Diarrhea, vomiting, stomach pain, nausea, stomach irritation (gastritis), stomach or intestinal bleeding, constipation
- •Fever, swelling of hands, feet, or face, tiredness, weakness
- •Respiratory tract infection, inflammation of the nose and throat, pneumonia, influenza, bronchitis
- •Changes in blood tests for liver, pancreas, or kidney function
- •Decreased appetite
- •Joint pain, back pain, headache, chest pain, muscle pain
- •Rash (itchy and/or widespread), hives, acne, sensitivity to sun/UV light
- •Cough, shortness of breath, fluid in the lining of the lungs
- •Dizziness, balance disorder, ringing in the ears (tinnitus), altered taste
- •Irregular heartbeat, high blood pressure, fluid around the heart, abnormally high blood pressure in the lungs
- •Low white blood cell count (leukopenia), high potassium in blood, low phosphorus in blood, severe dehydration, acute kidney failure, worsening kidney function
- •Allergic reaction, acute pancreatitis, respiratory failure
RARE
- •Fever with a low white blood cell count (febrile neutropenia)
- •Severe liver damage
- •Life-threatening allergic reaction (anaphylactic shock)
- •Abnormal fluid buildup in the lungs (acute pulmonary edema)
- •Severe skin rashes (like erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, or peeling rash)
- •Inflammation of the heart sac (pericarditis)
- •Significant drop in granulocytes (a type of white blood cell)
- •Symptoms of tumor lysis syndrome (TLS), such as nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, tiredness, and abnormal blood tests (high potassium, uric acid, phosphorus; low calcium), leading to kidney problems.
- •Interstitial lung disease (a condition causing lung scarring) with symptoms like cough, difficulty breathing, and pain when breathing
Important Warnings
- Do not take this medicine if you are allergic to bosutinib or if your doctor has told you that you have severe liver damage or your liver isn't working normally.
- Tell your doctor if you have or have had liver problems. Watch for symptoms like itching, yellow skin or eyes, dark urine, or pain in the upper right side of your stomach.
- Tell your doctor if you have severe diarrhea or vomiting, especially if it contains blood or is black and tar-like.
- Tell your doctor if you notice unusual bleeding or bruising without injury.
- Tell your doctor if you have signs of an infection like fever, painful urination, cough, or sore throat.
Show 11 more warnings
- Tell your doctor if you have swelling in your ankles, feet, or legs, difficulty breathing, chest pain, or cough, as these can be signs of fluid buildup.
- Tell your doctor if you have heart problems, especially if you faint or have an irregular heartbeat.
- Tell your doctor if you have kidney problems, changes in how often you urinate, or swelling in your feet, ankles, hands, or face.
- Tell your doctor if you have ever had Hepatitis B, as this medicine can reactivate the virus, which can be serious.
- Tell your doctor if you have or have had problems with your pancreas, like stomach pain or discomfort.
- Tell your doctor immediately if you develop a severe, painful red or purplish rash that spreads and forms blisters, especially in your mouth or on your lips.
- Tell your doctor if you have side pain, blood in your urine, or urinate less often, as these could be signs of a serious condition called tumor lysis syndrome.
- This medicine can make you more sensitive to sun and UV light. Protect your skin from sun exposure and use high SPF sunscreen.
- Do not use this medicine if you are pregnant or breastfeeding. It may affect fertility, so discuss sperm preservation with your doctor if needed. Women must use effective birth control during and for at least 1 month after treatment.
- If you feel dizzy, have blurry vision, or feel unusually tired, do not drive or use machines until these effects have gone away.
- Do not take this medicine with grapefruit or grapefruit juice, as it can increase the risk of side effects.